On behalf of people with CF and their families, the CF Foundation has notified the U.S. Food and Drug Administration (
Distribution of the
Manufacturers were given six years to satisfy requirements set by the FDA. To date, the FDA has approved three enzyme products: ZENPEP®, Creon® and PancreazeTM. The Foundation is working closely with the FDA to find ways to reduce the burden on individuals with CF who rely on Pancrecarb and Ultrase.
In 2004, the FDA launched the review of enzymes, which had previously been unregulated. The Foundation supported this process because of concern that some of the enzymes available at the time were interfering with
More than 90 percent of people with cystic fibrosis take enzyme supplements to help absorb food and vitamins. Without pancreatic enzymes, people with CF could not survive.
“Our top priority is the safety and health of people with cystic fibrosis, and we continue to work closely with the FDA and our accredited CF care centers to assure patients receive safe and effective therapies,” said Preston W. Campbell, III, M.D. executive vice president for medical affairs for the Cystic Fibrosis Foundation.
“We understand the FDA review has caused a difficult transition for some people with CF, and our hope is they will work closely with a cystic fibrosis physician at an accredited CF Foundation care center to find a solution. It is essential that all therapies used by patients be regulated and approved by the FDA to ensure everyone's short-and long-term safety.”
At this time, no additional information is available on the timeframe for approval of the remaining enzymes.
- FDA responds to questions about using approved pancreatic enzyme products.